Summarize in a written document recommendation for clinical trial design, adverse event reporting and analysis of transplant-specific outcomes. This document will be submitted for publication.

Participants:Invited participants (limit of 20) and observers will include representatives from the academic transplant community, the Food and Drug Administration, the National Institutes of Health, the American Society for Blood and Marrow Transplantation, the Foundation for the Accreditation of Hematopoietic Stem Cell Transplantation, the International Society of Hematotherapy and Graft Engineering, the National Marrow Donor Program, the International Bone Marrow Transplant Registry and the Autologous Blood and Marrow Transplant Registry. Participants will be assigned to one of three subcommittees charged with developing recommendations and leading a discussion I one of the three main Forum areas: Clinical Trial Design, Adverse Event Reporting and Transplant-Specific Outcomes. Observers will be invited to comment on the recommendations.